Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women
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Purpose
Osteopenia and osteoporosis cause thinning of bone tissue and loss of bone density over time. The purpose of this study is to determine the safety and effectiveness of nitroglycerin ointment for the treatment of osteopenia in postmenopausal women.
Study hypothesis: On average, participants in the base therapy cohort who receive placebo ointment control and calcium/vitamin D will lose more bone density than participants in the nitroglycerin cohort over the 36-month period.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis Osteopenia |
Drug: Nitroglycerin ointment Drug: Calcium supplement with vitamin D |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Prevention of Postmenopausal Bone Loss With Nitric Oxide |
- DXA-measured BMD (bone mineral density) of lumbar vertebrae (L2 to L4)
- DXA-measured BMD of dual hips (Ward's triangle, femoral neck, and trochanter)
- serum osteocalcin
- BS-ALP
- serum N-telopeptide
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2002 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Imbalance in the activities of osteoclasts (cells responsible for bone loss) and osteoblasts (cells responsible for bone formation) may lead to fractures, osteopenia, and osteoporosis in postmenopausal women. During postmenopause, decreased estrogen levels and decreased nitric oxide production occur; estrogen replacement therapy has been shown to restore serum nitric oxide levels to normal. Reversing nitric oxide deficiency by using nitroglycerin may prevent further bone loss. The Nitroglycerin as an Option: Value in Early Bone Loss (NOVEL) study will test the safety and efficacy of nitroglycerin ointment for the treatment of osteopenia in postmenopausal women.
Patients will be enrolled in the study for 3 years and will be randomly assigned to one of two groups. The first group will receive nitroglycerin ointment, while the second group will receive placebo ointment. All patients will be given a calcium supplement with vitamin D to be taken daily, and will be instructed to rub the given ointment on their skin daily. Study visits will occur at Month 2 and every six months after Month 2. Phone interviews will be conducted with patients every 2 months throughout the study.
Eligibility| Ages Eligible for Study: | 40 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Postmenopausal for a minimum of 13 months
- Lumbar spine T-score of 0 to -2.5 (0 to -2.0 if over 60 years old) by Dual Energy X-ray Absorptiometry (DEXA) (i.e., evidence of normal bone mass or osteopenia)
- Body Mass Index (BMI) between 18 and 32
- Planning to live in the greater New Brunswick, NJ, area for at least 3 years
Exclusion Criteria:
- Radiographically or DEXA-morphometrically proven vertebral or hip fracture
- Conditions requiring routine use of sublingual, transdermal, or oral nitrates
- Significant postmenopausal symptoms that require estrogen therapy
- Metabolic bone diseases other than postmenopausal bone loss (e.g., active hyperthyroidism, hyperparathyroidism, Paget's disease of bone, etc.)
- Insulin-dependent diabetes mellitus
- Significant migraine headaches
- History of renal calculi
- Cancer within 5 years prior to study entry
- Any condition causing an anticipated life expectancy of less than 3 years
- Failure to maintain 75% to 125% compliance with open-label calcium with vitamin D regimen during the screening period
Contacts and Locations| United States, New Jersey | |
| UMDNJ-Robert Wood Johnson Medical School, Department of Medicine, Division of Endocrinology | |
| New Brunswick, New Jersey, United States, 08903-0019 | |
| Principal Investigator: | Sunil J. Wimalawansa, MD, PhD | UMDNJ - Robert Wood Johnson Medical School, Division of Endocrinology |
More Information
No publications provided
| Responsible Party: | Sunil J. Wimalawansa , MD, PhD, UMDNJ - Robert Wood Johnson Medical School, Division of Endocrinology |
| ClinicalTrials.gov Identifier: | NCT00043719 History of Changes |
| Other Study ID Numbers: | R01 AR048679, NIAMS-069, NOVEL |
| Study First Received: | August 12, 2002 |
| Last Updated: | January 29, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
|
Human Female Osteoporosis Postmenopausal Nitric Oxide |
Nitroglycerin Calcium Vitamin D |
Additional relevant MeSH terms:
|
Bone Diseases, Metabolic Osteoporosis Osteoporosis, Postmenopausal Bone Diseases Musculoskeletal Diseases Vitamin D Ergocalciferols Vitamins Nitroglycerin Nitric Oxide Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
Vasodilator Agents Cardiovascular Agents Therapeutic Uses Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013